None listed
Conditions
Brief summary
Obstructive sleep apnoea (OSA) is a condition in which a patient’s airway repeatedly narrows or closes during sleep. This leads to low levels of oxygen and multiple awakenings throughout the night. Many factors contribute to the blockage of the upper airway during sleep, including the shape, length and strength of the upper airway itself. Oral appliances can improve airway size and can thus also improve OSA. Similarly, exercises that are focused on strengthening the orofacial muscles (Orofacial Myofunctional Therapy) can improve the airway and, therefore, reduce OSA severity. Orofacial Myofunctional Therapy involves exercises targeted to facial and oropharyngeal structures (lips, tongue, and the soft palate) and typically involve aspects of suction, breathing, and chewing. There is some evidence supporting the concept that orofacial myofunctional therapy improves OSA symptoms in adult patients, alongside other benefits including reduced snoring and improvements in sleep quality, oxygen saturation levels and daytime sleepiness. These therapeutic benefits are hypothesised to arise from muscle gain in the upper airway, from improvements in upper airway muscle responsiveness, and from improved coordination in the way that different compartments of tongue and other pharyngeal muscles are recruited together. This trial investigates potential benefits of using the combination of a passive myofunctional oral device along with an active myofunctional device designed to strengthen the oral and facial musculature on OSA severity. Aim: This study will investigate the efficacy of an oral appliance combined with tongue muscle exercises in improving OSA severity. Hypotheses: (1) Wearing the oral appliance for 2 weeks will improve objective measures of OSA severity compared to a baseline assessment conducted prior to commencing wearing the device. (2) Wearing the oral appliance in combination with exercise will be superior to wearing the appliance without exercise in improving objective measures of OSA severity.
Interventions
This study will employ the use of two devices: the Myosa S1 and Myosa S1®Hybrid (S1H) device.
The S1 device is typically used to progressively rehabilitate patients with TMJ and airway disorders. It has appliance features which passively position the patients jaw and muscles into an ideal position to decompress the TMJ and open the airway. The device consists of 4 breathing holes which regulate oral breathing, a tongue elevator and tongue tag which lift the tongue into correct position out of a
This study will employ the use of two devices: the Myosa S1 and Myosa S1®Hybrid (S1H) device. The S1 device is typically used to progressively rehabilitate patients with TMJ and airway disorders. It has appliance features which passively position the patients jaw and muscles into an ideal position to decompress the TMJ and open the airway. The device consists of 4 breathing holes which regulate oral breathing, a tongue elevator and tongue tag which lift the tongue into correct position out of airway, a lip bumper to retrain the atypical swallow, and an edge to edge offset and thick base to open the airway. The S1H is a similar device to the S1 but with additional 'active' features (i.e. includes tongue, lip and jaw press tubes) which allow the patient to press on, and actively exercise tongue lip and jaw muscles respectively. An exercise program is used along with the S1H to fatigue the oral and airway muscles while bringing awareness to nasal breathing. Over a total of 14 weeks use of the Myosa S1 and Myosa S1®Hybrid (S1H) devices in two phases: Phase 1: Weeks 1 & 2 will involve wearing the S1 appliance for 1-2 hours while awake and overnight while asleep. Phase 2: Week 3-14 will repeat the appliance prescription for Phase I (i.e. Participants will continue to use the S1 appliance overnight and 1-2 hours per day), in addition to the use of prescribed active muscle exercising. The muscle training will be accomplished by using the active S1H appliance features for 10min twice a day. Following an initial baseline polysomnography (PSG), participants will commence Phase 1, after which a follow-up PSG will be repeated at the end of Phase 1. After Phase 1 is complete, Phase 2 will commence and conclude at the end of week 14 with a final PSG. Description of the active muscle exercising to be performed during each week of Phase 2 of the trial with the S1H: Weeks 3-6: Lips - Press and release x 3 then press and hold closed for 3 light slow gentle nasal breaths. Tongue - Press and release x 3 times then press and hold for 3 breaths. Jaw - Press and release x 3 then press and hold jaw and lip tube for 3 nasal breaths. Repeat series 2 times. Weeks 7-10: Lips - Press and release x 5 then press and hold closed for 5 light slow gentle nasal breaths. Tongue - Press and release x 5 times then press and hold for 5 breaths. Jaw - Press and release x 5 then press and hold jaw and lip tube for 5 nasal breaths. Repeat series 2 times. Weeks 11-14: Lips - Add head tilt and press and release x 5 then press and hold closed for 5 light slow gentle nasal breaths. Tongue - Add head tilt and press and release x 5 times then press and hold for 5 breaths. Jaw - Add head tilt and jaw press and release x 5 then press and hold jaw and lip tube for 5 nasal breaths. Repeat series 2 times. Participants will be asked to complete a daily logbook to monitor adherence to the program.
Sponsors
Monash University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Otherwise healthy patients with obstructive sleep apnoea, as diagnosed by an AHI between 5 and 50 events/hr inclusive.
Exclusion criteria
• Obesity (BMI > 32 kg/m2) • Sleep disorder other than OSA, including narcolepsy • ESS >15 (out of 24 points at Screening) • Clinically significant craniofacial malformation • Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or uncontrolled hypertension • Clinically significant neurological disorder (including epilepsy/convulsions) • Clinically significant cognitive dysfunction • Participants who have had upper airway surgery < 1 year before the trial • Respiratory disorders (including asthma) • Participants with central sleep apnea (central apnea index >10 /hr and more than 50% of respiratory events classed as central) • Participants undergoing concomitant treatment for snoring/OSA or who have discontinued CPAP < 1 week before the trial • Participants with severe sleep apnea (AHI >30) • Participants with OSA associated with a syndrome or genetic disorder • Participants with uncontrolled diabetes • Participants with diagnosed active depression/anxiety (self-report on the HADS) • Participants with allergies to the appliance material • Women who are pregnant or breastfeeding • Participants with full or partial dentures • Participants with acute TMJ issues • Participants with active periodontal disease, teeth, or other jaw disorders which may be impacted by an intraoral appliances • Typical sleep duration < 4 hours • Motor vehicle accident or near-miss motor vehicle accident in the past 2 years related to sleepiness, tiredness or fatigue • Participants on medications that will substantially affect respiration, including (but not limited to) opioids, barbiturates, theophylline, doxapram, acetazolamide, pseudoephedrine • Unwilling to limit caffeinated beverage intake (e.g., coffee, cola, tea) to 400 mg/day or less of caffeine (approximately 4 cups of coffee); caffeine not to be used within 3 hours of bedtime • Any condition that in the investigator’s opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation • Participant considered by the investigator, for any reason, an unsuitable candidate to use the oral appliance, or unable or unlikely to understand or comply with the study instructions or study evaluations
Outcome results
None listed